Intervertebral implants having positioning grooves and kits and methods of use thereof

ABSTRACT

Spinal implants, spinal implant systems, and methods for inserting spinal implants are provided. The implants can be implanted in an intervertebral space between adjacent superior and inferior vertebrae. The implant includes a superior implant surface having one or more superior positioning grooves configured to receive a corresponding superior positioning rail and an inferior implant surface having one or more inferior positioning grooves configured to receive a corresponding inferior positioning rail when the implant is implanted in the intervertebral space.

TECHNICAL FIELD

The present disclosure generally relates to intervertebral implants andmethods of use thereof.

BACKGROUND

The spinal disc and/or vertebral bodies can be displaced or damaged dueto trauma, disease, degenerative defects, or wear over an extendedperiod of time. One result of this displacement or damage to a spinaldisc or vertebral body can be chronic back pain. Intervertebral discdegeneration impacts the majority of people, with more than 60% ofpatients beyond age 40 displaying some level of disc degeneration on anMRI. This is most prevalent in the lumbar spine.

The standard treatment for chronic pain related to damaged or displaceddiscs or segmental instability is lumbar spinal fusion. There are twomain types of lumbar spinal fusion, which can be used in conjunctionwith each other. Posterolateral fusion places the bone graft between thetransverse processes in the back of the spine. These vertebrae are thenfixed in place with screws and/or wire through the pedicles of eachvertebra attaching to a metal rod on each side of the vertebrae.Interbody fusion places the bone graft between the vertebra in the areausually occupied by the intervertebral disc. In preparation for thespinal fusion, the inner nucleus pulposus is removed entirely. A devicesuch as an intervertebral cage or implant can be placed between thevertebra to restore proper spine alignment and disc height.

Cervical spinal fusions can be performed on the neck. Bone, metalplates, or screws can make a bridge between adjacent vertebrae. Inadvanced cases, whole vertebrae can be removed before the fusion occurs.Usually, however, only the intervertebral disk is removed, and aspacer—commonly made of metal, bone or PEEK—is subsequently inserted,allowing for the vertebrae to eventually heal together. Cervical spinalfusion can be performed for several reasons. Following injury, thissurgery can help stabilize the neck and prevent fractures of the spinalcolumn which could damage the spinal cord. It can also treat misalignedvertebrae or as a follow up for other spinal injuries. Cervical spinalfusion can remove or reduce pressure on nerve roots caused by bonefragments or ruptured intervertebral disks.

The success or failure of spinal fusion depends on several factors. Forinstance, the spacer or cage used to fill the space left by the removeddisc and bony anatomy must be sufficiently strong to support the spineunder a wide range of loading conditions. The implant should also beconfigured to remain in place once it has been positioned in the spineby the surgeon. Additionally, the bone graft materials used should bebiocompatible and promote bony ingrowth. Facilitation of boneyarthrodesis (fusion) is a desirable property of an interbody implant.

Common causes of failure in spinal fusion include slippage of theimplant, breakage of the plates, or the backing out of screws thatsecure the implant. Screws back out, typically as a result of thefailure of the screws to achieve a sufficient purchase in the bone;although the stripping of the threads on the screws also causes thisproblem. However, the hardware failures associated with the implantitself may include slippage, improper placement, or improper fit to thespinal geometry. There is a need for improved devices for spinal fusionand for improved, less invasive methods for achieving spinal fusion.

Therefore, it is an object of the disclosure to provide improvedintervertebral implants that can be easily placed and with improved fitas compared to existing implants.

It is further an object of the disclosure to provide improvedintervertebral fusion implants that remain in place followingimplantation.

It is further an object of the disclosure to provide improved and safermethods for spinal fusion, in particular for lumbar or cervical spinalfusion.

SUMMARY

Embodiments of the present disclosure provide for spinal implants andsystems for surgical implants and placement thereof.

An embodiment of the present disclosure includes a spinal implant. Theimplant can include a superior implant surface having one or moresuperior positioning grooves configured to receive a correspondingsuperior positioning rail. The implant can also include an inferiorimplant surface having one or more inferior positioning groovesconfigured to receive a corresponding inferior positioning rail. One ormore implant sidewalls can separate the superior implant surface and theinferior implant surface.

Another embodiment of the present disclosure includes a system forsurgical implants. The system can include a positioning tool comprisingat least one positioning rail and a spinal implant as above.

Other systems, methods, features, and advantages of the devices andmethods will be or become apparent to one with skill in the art uponexamination of the following drawings and detailed description. It isintended that all such additional systems, methods, features, andadvantages be included within this description, be within the scope ofthe present disclosure, and be protected by the accompanying claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Further aspects of the present disclosure will be readily appreciatedupon review of the detailed description of its various embodiments,described below, when taken in conjunction with the accompanyingdrawings.

FIG. 1 is a sectional dexter view onto the sagittal plane of anidealized intervertebral space. For clarity the intervertebral implantis not drawn.

FIGS. 2A-2C depict an exemplary anterior cervical discectomy and fusion(ACDF) implant. FIG. 2A is a perspective view of the exemplary cervicalACDF implant. FIG. 2B is a side view of the exemplary cervical ACDFimplant. FIG. 2C is a top view of the exemplary cervical ACDF implant.Dashed lines are drawn to aid the viewer.

FIG. 3 is a side view of a second exemplary anterior cervical discectomyand fusion (ACDF) implant having a curvature to match the lordoticcurvature of the cervical spine and a textured superior and inferiorsurface.

FIG. 4 is a top view of a third exemplary anterior cervical discectomyand fusion (ACDF) implant having a contour to match the vertebral body.

FIG. 5 is a side view of a fourth exemplary anterior cervical discectomyand fusion (ACDF) implant having a convex superior and inferior surface.

FIGS. 6A-6B depict an exemplary cervical corpectomy implant. FIG. 6A isa side view of the exemplary corpectomy implant. FIG. 6B is a top viewof the exemplary corpectomy implant.

FIGS. 7A-7C depict an exemplary thoracolumbar implant designed for alateral approach. FIG. 7A is a perspective view of the exemplarythoracolumbar implant. FIG. 7B is a side view of the exemplarythoracolumbar implant. FIG. 7C is a top view of the exemplarythoracolumbar implant.

FIG. 8 is a side view of a second exemplary thoracolumbar implant.

FIGS. 9A-9B depict an exemplary posterior lumbar interbody fusion (PLIF)implant. FIG. 9A is a perspective view of the exemplary PLIF implant.FIG. 9B is a side view of the exemplary PLIF implant.

FIG. 10 is a side view of a second exemplary PLIF implant.

FIGS. 11A-11B depict an exemplary transforaminal lumbar interbody fusion(TLIF) implant. FIG. 11A is a perspective view of the exemplary TLIFimplant. FIG. 11B is a top view of the exemplary TLIF implant.

FIGS. 12A-12B depict an exemplary anterior lumbar interbody fusion(ALIF) implant. FIG. 12A is a perspective view of the exemplary ALIFimplant. FIG. 12B is a top view of the exemplary ALIF implant. FIGS.12C, 12D, and 12E provide additional examples of possible positioningrail placement.

FIG. 13A depicts an exemplary positioning tool having removableattachments. FIGS. 13B-13E depict embodiments of the removableattachments. FIG. 13F is another possible embodiment of the positioningtool or distractor-caliper.

FIGS. 14A-14B are examples of stabilization (button) plates forretention and stabilization of the implants.

FIGS. 15A-15B depict exemplary affixing tools for placement of thebutton plates in FIGS. 14A-14B.

FIGS. 16A and 16B are examples of an impaction tool.

DETAILED DESCRIPTION

In various aspects, intervertebral implants for implantation in anintervertebral space between adjacent superior and inferior vertebraeare provided. The implants include a plurality of positioning grooveslocated on superior and inferior surfaces that can be slidably engagedby appropriately placed positioning rails on a device such as adetractor to allow for placement of the implant in the intervertebralspace with greater ease and with greater retention in the intervertebralspace.

Before the present disclosure is described in greater detail, it is tobe understood that this disclosure is not limited to particularembodiments described, and as such may, of course, vary. It is also tobe understood that the terminology used herein is for the purpose ofdescribing particular embodiments only, and is not intended to belimiting. The skilled artisan will recognize many variants andadaptations of the embodiments described herein. These variants andadaptations are intended to be included in the teachings of thisdisclosure and to be encompassed by the claims herein.

All publications and patents cited in this specification are cited todisclose and describe the methods and/or materials in connection withwhich the publications are cited. All such publications and patents areherein incorporated by references as if each individual publication orpatent were specifically and individually indicated to be incorporatedby reference. Such incorporation by reference is expressly limited tothe methods and/or materials described in the cited publications andpatents and does not extend to any lexicographical definitions from thecited publications and patents. Any lexicographical definition in thepublications and patents cited that is not also expressly repeated inthe instant specification should not be treated as such and should notbe read as defining any terms appearing in the accompanying claims. Thecitation of any publication is for its disclosure prior to the filingdate and should not be construed as an admission that the presentdisclosure is not entitled to antedate such publication by virtue ofprior disclosure. Further, the dates of publication provided could bedifferent from the actual publication dates that may need to beindependently confirmed.

Although any methods and materials similar or equivalent to thosedescribed herein can also be used in the practice or testing of thepresent disclosure, the preferred methods and materials are nowdescribed. Functions or constructions well-known in the art may not bedescribed in detail for brevity and/or clarity. Embodiments of thepresent disclosure will employ, unless otherwise indicated, techniquesof neurosurgery and orthopedic surgery as well as medical device designand engineering and the like, which are within the skill of the art.Such techniques are explained fully in the literature.

It should be noted that ratios, concentrations, amounts, and othernumerical data can be expressed herein in a range format. It is to beunderstood that such a range format is used for convenience and brevity,and thus, should be interpreted in a flexible manner to include not onlythe numerical values explicitly recited as the limits of the range, butalso to include all the individual numerical values or sub-rangesencompassed within that range as if each numerical value and sub-rangeis explicitly recited. To illustrate, a numerical range of “about 0.1%to about 5%” should be interpreted to include not only the explicitlyrecited values of about 0.1% to about 5%, but also include individualvalues (e.g., 1%, 2%, 3%, and 4%) and the sub-ranges (e.g., 0.5%, 1.1%,2.2%, 3.3%, and 4.4%) within the indicated range. Where the stated rangeincludes one or both of the limits, ranges excluding either or both ofthose included limits are also included in the disclosure, e.g. thephrase “x to y” includes the range from ‘x’ to ‘y’ as well as the rangegreater than ‘x’ and less than ‘y’. The range can also be expressed asan upper limit, e.g. ‘about x, y, z, or less’ and should be interpretedto include the specific ranges of ‘about x’, ‘about y’, and ‘about z’ aswell as the ranges of ‘less than x’, less than y′, and ‘less than z’.Likewise, the phrase ‘about x, y, z, or greater’ should be interpretedto include the specific ranges of ‘about x’, ‘about y’, and ‘about z’ aswell as the ranges of ‘greater than x’, greater than y′, and ‘greaterthan z’. In some embodiments, the term “about” can include traditionalrounding according to significant figures of the numerical value. Inaddition, the phrase “about ‘x’ to ‘y’”, where ‘x’ and ‘y’ are numericalvalues, includes “about ‘x’ to about ‘y’”.

Definitions

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this disclosure belongs. It will be further understoodthat terms, such as those defined in commonly used dictionaries, shouldbe interpreted as having a meaning that is consistent with their meaningin the context of the specification and relevant art and should not beinterpreted in an idealized or overly formal sense unless expresslydefined herein.

The articles “a” and “an,” as used herein, mean one or more when appliedto any feature in embodiments of the present invention described in thespecification and claims. The use of “a” and “an” does not limit themeaning to a single feature unless such a limit is specifically stated.The article “the” preceding singular or plural nouns or noun phrasesdenotes a particular specified feature or particular specified featuresand may have a singular or plural connotation depending upon the contextin which it is used.

Some basic terms and measures used to characterize the regions anddimension of the intervertebral space are depicted in FIG. 1 . FIG. 1 isa dexter projection into the sagittal plane of the body of theintervertebral space 100 between an idealized superior (upper) vertebraA and an idealized inferior (lower) vertebra B. The reverse cageintervertebral implant and the intervertebral disc is removed in FIG. 1for clarity. The intervertebral implants have a suitable shape anddimension so as to fit into the intervertebral space 100, engaging thesuperior vertebral surface a and the inferior vertebral surface b, andsuch that the spacer extends from the anterior region 102 of theintervertebral space 100 to the posterior region 104 of theintervertebral space 100.

Implants Having One or More Positioning Grooves

A variety of implants are provided for implantation in an intervertebralspace between adjacent superior and inferior vertebrae. The implants caninclude one or more positioning grooves on the superior surface of theimplant and one or more positioning grooves on the inferior surface ofthe implant to allow for ease of placement with improved fit andpositioning. In particular, the one or more positioning grooves can beof a suitable size, shape, and orientation on the implant such that apositioning tool having one or more positioning rails can engage thepositioning grooves.

In some embodiments, radiopaque markers may be incorporated into theimplants to allow for radiographic localization of radiolucent implants.

A variety of positioning tools are also provided. The positioning toolsinclude one or more positioning rails that correspond to one or morepositioning grooves. For example, the positioning rails can be part of avertebral distractor-inserter such that the rails insert in thepositioning grooves. In certain embodiments, the positioning rails canbe about 1 mm wide and about 1 mm to 1.5 mm high to engage with thepositioning grooves on the implant. In certain embodiments, thepositioning rails can have a length of about 10 to 12 mm in length forsuch as a cervical implant device. In other embodiments, the positioningrails can have a longer length for use in other devices (e.g. thoracic,lumbar, etc) of a different size. The positioning tools are described infurther detail below.

Textured, Featured or Irregular Surface

Each surface of the intervertebral implant can partially or entirelyinclude a featured and/or a textured or irregular surface. The featuresor texture on the surface(s) increase the frictional resistance betweenthe surfaces of the implant and the adjacent vertebral bodies comparedto the same surface without the features or texture, thereby increasingthe stability of the implant within the patient's spine. One or more ofthe surfaces can include a plurality of features such as sharp ridges. Afeatured surface can include a plurality of deforming features such asridges, grooves, dimples, nodules, bumps, raised portions or patterns,or any combination thereof. A textured surface can have any surfaceroughness. In some embodiments a textured surface has a surfaceroughness from 1 micron to 2 mm, from 0.01 mm to 1.5 mm, from 0.1 mm to1.5 mm, or from 0.25 mm to 1.0 mm.

Materials

The intervertebral implants provided herein, the superior and inferiorsurfaces, the sidewalls, etc., can be made from any suitable materialhaving the desired mechanical properties and level of biologicalcompatibility.

The implant, the superior and inferior surfaces, the sidewalls, the bonescrews, the blades, etc., or any combination thereof can in someembodiments be made from a thermosetting polymer. Suitable thermosettingpolymers include, but are not limited to, polyetherketoneketone (PEKK)and polyetheretherketone (PEEK). PEEK is particularly suitable becauseits modulus of elasticity closely matches that of bone. However, PEEK isalso a hydrophobic material and bacteria tend to adhere easily to thesetypes of surfaces.

In some embodiments a thermoplastic resin material, such as PEEK, ismodified to increase surface hydrophobicity and/or is coated with anantibacterial agent. Biologically stable thermosetting polymers include,but are not limited to, polyethylene, polymethylmethacrylate,polyurethane, polysulfone, polyetherimide, polyimide, ultra-highmolecular weight polyethylene (UHMWPE), cross-linked UHMWPE and membersof the polyaryletherketone (PAEK) family, including polyetheretherketone(PEEK), carbon-reinforced PEEK, and polyetherketoneketone (PEKK). Insome cases, the implant contains a substrate material, such as titanium,onto which a thermosetting polymer is coated.

The implant, the superior and inferior surfaces, the sidewalls, the bonescrews, the blades, etc., or any combination thereof can in someembodiments be made from or include other suitable implantablematerials, including but not limited to ceramic, titanium alloy,aluminum alloy, steel alloy, gallium, cobalt-chrome, or other materialsas can be understood by one of ordinary skill in the art.

The implant, the superior and inferior surfaces, the sidewalls, the bonescrews, the blades, etc., or any combination thereof can in someembodiments be formed or partially formed using additive manufacturing(e.g. 3D printing). The implant may be manufactured with an additiveand/or subtractive finish to improve surface characteristics includingbut not limited to acid etching, addition of implant material,hydroxyapatite coating, etc.

In some embodiments, the implant material or portions thereof can beporous to mimic trabecular structure and/or to allow forosseointegration.

The blades and/or bone screws are typically made from a metal or metalalloy, such as stainless steel or titanium.

Stabilization Means

Generally, the implant contains suitable stabilization means. Suitablestabilization means secures the implant to the intervertebral space. Thestabilization means can be anything capable of mechanically engagingboth the implant and the adjacent vertebral bodies in a manner thatstabilizes the implant in the intervertebral space. Suitablestabilization means may be mechanical elements such as blades or bonescrews in various orientations. Alternatively, the stabilization meansmay be an adhesive such as adhesive materials or adhesive surfaces onthe implant, or friction, such as due to the fit of the particular shapeof the implant in the intervertebral space (e.g., friction fit, or “lockand key”). Optionally, the implant contains combination of differentstabilization means. In preferred embodiments the stabilization meansare bone screws, although one skilled in the art can recognize manyother alternative stabilization means. These embodiments are understoodto be encompassed as well.

Methods of Use

The intervertebral implants are useful for intervertebral fusion of twoor more adjacent vertebral bodies, especially in the lumbar spine.Optionally, the implants are implanted in the cervical spine as part ofan intervertebral fusion procedure. In addition to intervertebral fusionapplications, the devices and methods described herein can alsofacilitate the insertion of other devices including but not limited tototal disc arthroplasty devices.

In still other embodiments, the implants and methods described hereincan be used for hemicorpectomy or corpectomy. As can be envisioned byone of ordinary skill in the art, the implants described herein can beuseful elsewhere in the body, wherever surgical distraction is needed toseparate two body parts and release tension to remove material (e.g.mandibular, ankle, or other joint surfaces).

The implant is configured for placement within an intervertebral spacebetween the adjacent vertebrae previously occupied by a spinal disc.Following implantation, the low-profile reverse cage intervertebralimplant provides stabilization and torsional resistance to promotefusion of adjacent vertebrae of the spine.

Procedures for placing intervertebral implants generally include thefollowing steps, each of which are described in more detail below: (1)creation of an approach to the selected disc; (2) complete or partialremoval of the selected disc or disc material (annulus and/or nucleus),e.g., discectomy; and (3) insertion of the intervertebral implant,optionally including placement of one or more retention devices. Removalof part of a vertebral body (hemicorpectomy), all of one vertebral body(corpectomy), or multiple vertebral bodies (corpectomies) may bereconstructed with variants of this system.

An approach through the soft tissue (i.e. skin, muscles, faciae) to aselected intervertebral disc(s) is created such that the soft tissuepreferably is kept away from the site and the working area, e.g., by aretractor tool or cannula. The purpose of the approach is to provide asuitable surgical approach and exposure to the appropriate degenerativedisc level.

After a suitable approach is achieved, the surgeon removes the affecteddisc material, such as for example the annulus, nucleus or both orportions thereof, with, e.g., curettes, or rongeurs or otherinstruments. The purpose of this step is to provide adequate discectomyand intervertebral endplate preparation, as well as for decompression ofthe spinal cord/nerve roots. As described above, this may involvehemicorpectomy, corpectomy, and/or multiple corpectomies.

After discectomy and endplate preparation, the endplates or vertebraemay be distracted to augment the intersection between the endplates andto create sufficient space for intervertebral implant. One way toperform this step is to use a distraction instrument. In some aspects,the distraction instrument includes two or more positioning rails (alsoreferred to as placement rails) for slideably engaging the two or morepositioning grooves (also referred to as placement grooves) on animplant described herein. The rails can include a vertebral contactingportion that can be used for distraction of the superior and inferiorvertebrae. In some aspects, less distraction is required than wouldnormally be required with conventional implants because the rails aresized and shaped to slideably engage the positioning grooves. This canallow for a less obtrusive installation of the implant.

Next, the surgeon inserts the intervertebral implant in the appropriateposition. Proper implant placement is beneficial to ensure optimalresults, including segmental motion preservation. The implant, and inparticular the positioning grooves, can slideably engage the rails suchthat the implant can be slid along the rails and into place in theintervertebral space. It is believed that, because of the less obtrusiveinsertion means, the implants can be placed more easily and with abetter fit, resulting in less risk of slippage or relocation aftersurgery and a better fit to the intervertebral space. After the implantis inserted, one or more retention means may be used to retain theimplant in place in the intervertebral space and the distractioninstrument may be removed. For example, one or more screws or blades canbe extended through the superior and/or inferior vertebrae to engage theimplant and retain the implant in place in the intervertebral space. Theretention tools can include button plates and affixing tools asdescribed below.

The intervertebral space between vertebral bodies may be approached withdifferent techniques. Several techniques have been described, such asanterior transperitoneal, trans-psoas (true lateral) or posteriorapproach through median incision. Another technique involves anextraforaminal approach for the insertion of spinal disc implants.

Exemplary Embodiments

Although the invention is illustrated and described herein withreference to various specific embodiments, the invention is not intendedto be limited to the details of the particular embodiments. Therefore,while various modifications may be made in the details and within thescope and range of equivalents of the claims, these are not departingfrom the invention. The specific embodiments described herein are to beregarded as “illustrative of” the intervertebral implants.

Anterior Cervical Discectomy and Fusion (ACDF) Implant

FIGS. 2A-2C depict exemplary aspects of an ACDF implant 200. FIG. 2A isa perspective view of the exemplary cervical ACDF implant from theanterior view. FIG. 2B is a side view of the exemplary cervical ACDFimplant. FIG. 2C is a top view of the exemplary cervical ACDF implant.The implant 200 has a superior implant surface 201 having a firstsuperior positioning groove 211 and a second superior positioning groove212. The implant 200 has an inferior implant surface 202 having a firstinferior positioning groove 221 and a second inferior positioning groove222. The superior implant surface 201 is configured for engaging asuperior vertebral surface when the implant is implanted in theintervertebral space. Likewise, the inferior implant surface 202 isconfigured for engaging an inferior vertebral surface when the implantis implanted in the intervertebral space. In some embodiments, such asfor anterior cervical applications, the implant can have ananterior-posterior length of about 11 mm to 14 mm or about 11 mm, amediolateral width of about 10 mm to 16 mm or about 12 mm, and a heightat the anterior wall of about 4 mm to 100 mm. In the depictedembodiment, the anterior wall has a height of about 4 mm to 14 mm.

The superior implant surface 201 and inferior implant surface 202 areseparated by a plurality of sidewalls, e.g. an anterior wall 232 and aposterior wall 231 along with a first side wall 233 and a second sidewall 234. One or more cutouts 240 in the sidewalls can allow access tothe central void space 241 once the implant 200 is in place in theintervertebral space, e.g. for packing bone growth material and bridgingbone for lateral fusion.

FIG. 3 depicts second exemplary cervical ACDF implant 300 where theposterior wall 331 is shorter than the anterior wall 332 and theanterior wall 332 has a slight curvature to better accommodate thelordotic curvature of the cervical spine. The posterior wall 331 can beabout 2 mm to 4 mm shorter than the anterior wall 332, or about 4 mm to98 mm. The superior surface 301 and the inferior surface 302 can have anangulation between them, which can be approximately 6 degrees foranterior cervical applications, but other dimensions can be envisionedfor different applications. The superior surface 301 and the inferiorsurface 302 include a plurality of deforming features 360 creating atextured or irregular surface for improved retention in theintervertebral space. The side wall 334 also includes one or morecutouts 340 in the side walls, e.g. for packing bone growth material.

FIG. 4 depicts a top view of a third exemplary cervical ACDF implant 400where the anterior wall 432 is contoured to better match the contour ofthe vertebral body, and the first side wall 433 and second side wall 434taper from the anterior wall 432 to the posterior wall 431 Although thedepicted posterior wall 431 is flat, however the wall can also beconcave or otherwise shaped to accommodate the anatomy of a particularapplication. A central void space 441 can be present e.g. for packingbone growth material and bridging bone for lateral fusion once theimplant 400 is in place. In other embodiments, the implant may be solidand/or textured, without a bone growth void. Although not depicted,cervical ACDF implant 400 can include one or more superior positioninggrooves 411.

FIG. 5 depicts a side view of a fourth exemplary cervical ACDF implant500 where both the superior surface 501 and the inferior surface 502 areconvex (referred to as a “biconvex implant”) and have a plurality ofdeforming features 560 creating a textured or irregular surface forimproved retention in the intervertebral space. Although not depicted,cervical ACDF implant 500 can include one or more superior positioninggrooves 511.

Cervical Corpectomy Cage

FIG. 6A is a side view of the exemplary corpectomy implant 600. FIG. 6Bis a top view of the exemplary corpectomy implant 600. The anterior wall632 can be about 14 mm to 100 mm high. Anterior wall 632 and/orposterior wall 631 can be contoured. The first side wall 633 and secondside wall 634 taper outward from the anterior wall 632 to the posteriorwall 631. In other embodiments, the implant 600 can also taper in widthanteriorly to posteriorly. The superior surface 601 and the inferiorsurface 602 include a plurality of deforming features 660 creating atextured or irregular surface for improved retention in theintervertebral space. The superior implant surface 601 can have a firstsuperior positioning groove 611 and a second superior positioning groove612. The implant 600 can have an inferior implant surface 602 having afirst inferior positioning groove 621 and a second inferior positioninggroove 622. In some embodiments, there can be single superior andinferior positioning grooves.

Thoracolumbar and Interbody Fusion Implants

FIGS. 7A-7C depict an exemplary thoracolumbar implant designed for alateral approach. The implant 700 has a superior implant surface 701having a first superior positioning groove 711 and a second superiorpositioning groove 712. The implant 700 has an inferior implant surface702 having a first inferior positioning groove 721 and a second inferiorpositioning groove 722. FIG. 7A is an anterior perspective view of theexemplary thoracolumbar implant. A multifunctional window 741 functionsas a large port or graft window and can be present e.g. for packing bonegrowth material after insertion. Radiopaque markers 750 can be included.FIG. 7B is a side view of the exemplary thoracolumbar implant. In thisexample, both the superior surface 701 and the inferior surface 702 areflat. FIG. 7C is a top view of the exemplary thoracolumbar implant,showing deforming features 760 creating a textured or irregular surfacefor improved friction and/or retention. Said deforming features 760 canbe included on one or both of superior implant surface 701 and inferiorsurface 702. Multifunctional window 741 can also be seen from the topview. The implant can have a mediolateral length of about 30 mm to 60mm, an anterior-posterior width of about 10 to 20 mm, and a height atthe anterior wall of about 4 mm to 20 mm.

The positioning grooves can also be used to aid in the accurateplacement of instrumentation such as anterior plates.

FIG. 8 is a side view of a second exemplary thoracolumbar implant. Inthis example, both the superior surface 801 and the inferior surface 802are convex. The biconvex shape is an alternative embodiment to flatshapes such as in FIGS. 7A-7C to accommodate different endplate shapesand or a surgeon's preference. The implant can have a mediolaterallength of about 30 mm to 60 mm, an anterior-posterior width of about 10to 20 mm, and a height at the anterior wall of about 4 mm to 20 mm.

FIGS. 9A-9B depict an exemplary posterior lumbar interbody fusion (PLIF)implant. FIG. 9A is a perspective view of the exemplary PLIF implant.The implant 900 has a superior implant surface 901 having a singlesuperior positioning groove 911 and an inferior implant surface 902having a first inferior positioning groove 921. The single positioninggroove allows for insertion with a monorail tool. FIG. 9B is a side viewof the exemplary PLIF implant showing optional deforming features 960creating a textured or irregular surface for improved friction and/orretention. Said deforming features 960 can be included on one or both ofsuperior implant surface 901 and inferior surface 902. The anterior wallcan be taller than the posterior wall to create a tapered device. Theimplant can have an anterior-posterior length of about 15 mm to 30 mm, amediolateral width of about 8 to 15 mm, and a height at the anteriorwall of about 4 mm to 20 mm.

FIG. 10 is a side view of a second exemplary PLIF implant havingbiconvex superior and inferior surfaces to mimic the disc shape in theL4-S1 region where a PLIF implant is typically used. Although notdepicted, the implant 1000 has a superior implant surface 1001 having asingle superior positioning groove 1011 and an inferior implant surface1002 having a first inferior positioning groove 1021. The implant canhave an anterior-posterior length of about 15 mm to 30 mm, amediolateral width of about 8 to 15 mm, and a height at the anteriorwall of about 4 mm to 20 mm. In some embodiments, the anterior andposterior heights can be different from one another.

FIGS. 11A-11B depict an exemplary transforaminal lumbar interbody fusion(TLIF) implant. FIG. 11A is a perspective view of the exemplary TLIFimplant 1100. The implant 1100 has a superior implant surface 1101having a single superior positioning groove 1111 and an inferior implantsurface 1102 having an inferior positioning groove 1121. The TLIFimplant 1100 can have a superior curved profile. The single positioninggroove allows for insertion with a monorail tool. The prong of saidmonorail tool can be a small protrusion configured to fit into thegroove (not shown) or solitary prong for insertion into the superior andinferior positioning grooves 1111 and 1121. FIG. 11B is a top view ofthe exemplary TLIF implant. The TLIF superior positioning groove 1111and the inferior positioning groove 1121 can be mediolaterally curved. Adistractor/caliper positioning tool including a pin in place of apositioning rail can facilitate positioning by allowing the implant toturn along the grooves as it is inserted. As described in previousembodiments, the TLIF implant 1100 could also include deforming featureson one or both of superior implant surface 1101 and inferior implantsurface 1102. The implant can have an anterior-posterior length of about15 mm to 30 mm, a mediolateral width of about 8 to 15 mm, and a heightat the anterior wall of about 4 mm to 20 mm.

Anterior Lumbar Interbody Fusion (ALIF) Implants

FIGS. 12A-12B depict an exemplary anterior lumbar interbody fusion(ALIF) implant. The depicted implant can also be used for obliqueanterior insertion. The implant 1200 has a superior implant surface 1201having a first superior positioning groove 1211 and a second superiorpositioning groove 1212, along with oblique positioning grooves 1213 and1214. The implant 1200 has an inferior implant surface 1202 having afirst inferior positioning groove 1221 and a second inferior positioninggroove 1222, along with oblique positioning grooves 1223 and 1224. Theoblique positioning grooves are wider than the corresponding positioninggrooves 1211, 1212, 1221, and 1222 to allow for oblique cage insertionto accommodate the vena cava. For example, the diameter of the superiorand inferior positioning grooves can be about 1.5 mm, and the obliquepositioning grooves can have a diameter of about 2 mm. A central voidspace 1241 functions as a large port and can be present e.g. for packingbone growth material after insertion. In the figure, the obliquepositioning grooves on the superior side are hashed to distinguish themfrom the superior positioning grooves. FIG. 12A is an anteriorperspective view of the exemplary ALIF implant. FIG. 12B is a top viewof the exemplary ALIF implant.

FIGS. 12C-12E are additional non-limiting examples of possiblepositioning groove arrangements. Corresponding positioning rails on apositioning tool can be used. FIG. 12C shows an embodiment in whichpaired superior and inferior positioning grooves are offset from oneanother. FIG. 12D shows an embodiment in which there are an unmatchednumber of superior and inferior positioning grooves. In this particularembodiment, there is a single superior groove and a pair of inferiorgrooves. FIG. 12E provides an embodiment in which paired positioninggrooves are on the lateral edges of the implant, rather than thesuperior and inferior location of the other shown embodiments.

Implant Systems Including Positioning Tools

Distractor-Caliper Positioning Tools

Positioning tools, such as a distractor (also distractor-inserter ordistractor-caliper), can be used in conjunction with the implantsdescribed herein. The positioning tool can serve multiple functions. Thepositioning tool can include one or more positioning rails thatcorrespond to the positioning grooves on the implants as describedabove, acting similarly to a forklift for insertion of the implant upondistraction. The positioning rails can also function as a retractor toseparate bone or tissues. In some embodiments, the positioning tool caninclude a caliper scale, such that measurements can be taken and/or thetool arms can be locked open at a specific width.

The positioning tool can be modular, having a handle portioncorresponding to at least one removable attachment. The removableattachments can have various configurations that correspond to theimplant shapes described above. The attachments can be interchangeable,selected based on the type of implant needed. Advantageously, theoverall cost of the implant system can be lowered, and the flexibilityof the surgeon increased. For example, the implant can be provided tothe user with the appropriate attachment, allowing for a one-time toolpurchase of the handle. Alternatively, the handle can be provided with aset of attachments such that the user can select from any number ofimplants and have the appropriate tool. In some embodiments, the handleportion can be a clamp-type tension handle having two crossed arms, suchthat when user squeezes the handles together, the arms spread apart. Anattachment having positioning rails can be attached to each arm, thenumber and configuration of the positioning rails selected to correspondto the positioning grooves of a selected implant. Alternatively, thehandle portion can be similar to a rib spreader.

FIG. 13A depicts a possible embodiment of a positioning tool 1300 havingremovable attachments. The figure shows positioning tool 1300 as adistractor-caliper separating superior vertebra 1301 from inferiorvertebra 1302 to create an intervertebral space 1303 held open byattachments 1310 and arms 1320. Handles 1330 have been pressed together,causing arms 1320 to widen. Arms 1320 can be locked into place using anincremental locking mechanism such as teeth, a ratcheting mechanism, orthe like, and the distance measured using the scale 1340.

FIGS. 13B-13D depict embodiments of attachment 1310. Shown are pairs ofattachments 1310, one for each arm 1320 shown in FIG. 13A. Attachment1310 can have one or more positioning rails 1311. The depictedembodiments show two positioning rails 1311 per attachment 1310.However, in some embodiments, the positioning tool can have a singlepositioning rail 1311 on each attachment 1310 (e.g. for an implant suchas shown in FIG. 9A or 11A). The body of attachment 1310 can have aflange 1312 to lock the attachment to the positioning tool arms 1320.The attachment 1310 shown in FIG. 13C is curved to fit the spine andalign the positioning rails 1311 to the corresponding positioninggrooves on a selected implant. In some embodiments (not shown), thepositioning rails can be offset to accommodate non-orthogonalpositioning of the implant. FIG. 13D depicts another possibleembodiment, in which the body of the attachment 1310 is lipped to followthe contours of a curved implant, such as a TLIF (FIG. 11A). Thepositioning rails depicted have a half-cylindrical shape, but thepositioning rails may have a cylindrical shape or other shape as can beenvisioned by one of ordinary skill in the art, and can be coupled withpositioning grooves having an inverse profile.

FIG. 13E is another possible embodiment of the positioning tool ordistractor-caliper 1300.

As described in reference to FIGS. 13B and 13C, a flange can lock theattachment to a corresponding slot on the arm of the positioning tool.In other embodiments, the flange can be located on the arms and acorresponding slot can be located on the attachment. The attachments canbe attached by a variety of other means as can be envisioned by one ofordinary skill in the art.

In other embodiments, the positioning tool is not modular, and eachimplant type has a specific tool with corresponding positioning rails.

Plates for Stabilization Means

As described above, stabilization means such as bone screws or bladescan be used to affix the implant. The implant system can includestabilization plates and affixing tools to assist in screw and/or bladeplacement. The stabilization plate 1400 (FIGS. 14A and 14B) can haveapertures 1410 for screw placement, with one or more protrusions 1420(or buttons) for placement and alignment. The stabilization plate 1400shown in FIG. 14A is a lateral lumbar plate that can be used inconjunction with a thoracolumbar implant (such as FIG. 7A). Thestabilization plate 1400 shown in FIG. 14B is a cervical plate that canbe used in conjunction with an implant such as shown in FIG. 2A or 6A.The stabilization plate 1400 advantageously can fit onto a correspondingimplant such that the plate is prevented from sliding duringinstallation. The plate 1400 shown in FIG. 14A can also close the graftwidow sealing the central void space. The multifunctional window 741,such as shown in FIG. 7A, of the implant is configured to receive theprotrusion 1420 on the stabilization plate 1400 and also the impactiontool (such as FIGS. 16A and 16B). The affixing tool 1500 can include oneor more awls 1510 or prongs that correspond to the apertures 1410 in thebutton plate (FIG. 15A) and one or more receptacles 1520 to receive theprotrusions 1420 (FIG. 15B), such that the affixing tool and the buttonplate fit together to ensure that the awl punctures the bone in thelocation of the apertures. The affixing tool 1500 can have a handle 1530and can be used in conjunction with a mallet or other strikinginstrument to puncture the bone. The affixing tool 1500 can be used topuncture the bone to create starter holes for insertion of bone screws.The button receptacle 1520 can be used to assist the surgeon withpicking up the button plate 1400 for placement.

Impaction Tools

FIGS. 16A and 16B are examples of an optional impaction tool to allowfor graft material insertion into an implant after the implant is insitu. Generally, bone graft material is packed into an implant prior toplacement in a patient because it is difficult to pack the implant inplace without disrupting the position of the implant with the force ofimpaction. The impaction tools provided herein are designed to matespecifically with the implants such that the graft material can bepacked while the implant is in place while allowing for controlled forceby the surgeon and reducing the risk of over-impaction. For example, theimpaction tool shown in FIG. 16A includes a protrusion (or button)configured to mate with the multifunctional window 741 of an implantsuch as the one shown in FIGS. 7A-7C. In another example (FIG. 16B), theimpaction is performed by a stem configured to mate with the holeleading to the central void space, such as shown in FIGS. 2A, 9A, and11A. This embodiment can include safety rails, shown here having an “H”shape, which straddle the positioning rails of the positioning tool1300.

Advantageously, the stabilization plates, impaction tools, positioningtools, and implants described herein are designed to work in conjunctionwith one another as a system. The combination of these system componentsallows for impaction of the graft material after positioning of theimplant without graft material spillage. Existing implants are difficultto fill in situ without risking over-impaction. Through the combinationof complimentary impaction and positioning tools with the implants, thesystems described herein prevent over-impaction and provide the surgeonwith control and can mitigate force during insertion. The stabilizationplate is configured to receive the implant to prevent movement ormigration of the plate during screw placement. The distractor-caliperpositioning tool provides for a removable distractor without disturbingthe implant. The components of the system can work in concert to aid indetermining size of the implant, placement of the implant, packing ofgraft material, positioning of screws, and preventing damage tosurrounding structures.

The Structure of Intervertebral Discs and Implants

There are typically 24 intervertebral discs in the human spine,interspersed between the vertebral bodies. The intervertebral discs canbe identified by the two adjacent vertebrae, so the C6-C7 intervertebraldisc lies between the two most inferior of the cervical vertebraewhereas the T12-L1 intervertebral disc lies between the inferiorthoracic vertebra and the superior lumbar vertebra. The intervertebraldiscs generally increase in size moving down the spine, to approximately45 mm antero-posteriorly, 64 mm laterally and 11 mm in height in thelumbar region.

The majority of disc herniation occurs in the lumbar spine, typically(˜95%) in L4-L5 or L5-S1. The cervical spine is the second most commonsite of spinal disc herniation, typically at C5-C6 or C6-C7. Thoracicdisc herniation is the least common, occurring in less than 4% of cases.

The lumbar vertebrae graduate in size from L1 through L5. Themediolateral distance in the lumbar spine ranges from roughly 30-70 mm,with average values around 50 mm. The anteroposterior distance rangesfrom approximately 20-55 mm, with typical values around 35 mm.

The wedge angles (i.e., the angle between the superior and inferiorsurface of the intervertebral disc) typically graduate moving down thelumbar spine, increasing from 4°-10° as typical values for L1-L2intervertebral discs to 12°-16° as typical values for L5-S1intervertebral discs. The average wedge angle in the lumbar spineincreases with age, the average across all levels of the lumbar discsbeing less than 10° below age 30 and increasing to over 15° beyond age50. The average wedge angle observed from MRI and X-ray of theintervertebral space of 73 patients for TI2-LI is roughly 4°-5°, forL1-L2 is 5°-6°, for L2-L3 is 5.5°-6.5°, for L3-L4 is 6°-7°, for L4-L5 is8°-10°, and for L5-S1 is 12°-14°. See Mark Eijkelkamp. On theDevelopment of an Artificial Intervertebral Disc Diss., The Universityof Groningen, Groningen, Netherlands, 2002 and the references citedtherein.

Sometimes intervertebral heights (height between the superior vertebralsurface a and the inferior vertebral surface b) are reported as a singlevalue that can be the medial height or that can be an average of theanterior and posterior height as will be apparent by context. One ormore heights can also be reported as a range of values, such as a rangeof values observed for the different intervertebral spaces within apatient or as a range of values observed for a particular intervertebralspace observed across a range of patients.

The height in the anterior region for T12-L1 was observed to beapproximately 8-10 mm (average 9 mm), for L1-L2 approximately 9-12 mm(average 10.5 mm), for L2-L3 approximately 10-15 mm (average 12 mm), forL3-L4 approximately 10-16 mm (average 13 mm), for L4-L5 approximately12-16 mm (average 14 mm), and for L5-S1 approximately 9-16 mm (average13.5 mm). The medial heights range typically from 8-10 mm (average 9 mm)for T12-LI, 10-12 mm (average 11 mm) for L1-L2, from 11-16 mm (average13 mm) for L2-L3, from 11-17 mm (average 14) for L3-L4, from 12-16 mm(average 13 mm) for L4-L5, and from 9-13 mm (average 11 mm) for L5-S1.There is less variation in the posterior heights. The heights in theposterior region observed in the same population ranged from 5-8 mm(average 6.5 mm) for T12-L1, from 6-9 mm (average 7.5 mm) for L1-L2,from 7-12 mm (average 9 mm) for L2-L3, from 7-13 mm (average 10 mm) forL3-L4, from 7-11 mm (average 9 mm) for L4-L5, from 5-9 mm (average 7 mm)for L5-S1. See Mark Eijkelkamp. On the Development of an ArtificialIntervertebral Disc Diss., The University of Groningen, Groningen,Netherlands, 2002 and the references cited therein.

Based on measurements such as those provided above, the implantsdescribed herein can be manufactured to appropriate dimensions toaccommodate the average patient for specific anatomical locations. In anon-limiting example, the dimensions of an implant fora T12-L1 implantmay have an anterior wall height of 7 mm to 10 mm, whereas an implantfor L4-L5 may have an anterior wall height of 11 mm to 16 mm Inalternative embodiments, the implants can be bespoke for a particularpatient, such as via 3D printing based on measurements obtained throughimaging prior to surgery.

Methods for Use

The implants and systems described herein can be used during patientsurgery to optimize the amount of force required to insert the implantwhen compared with traditional methods, as well as allowing for morecontrolled distraction and insertion. The method can include performinga discectomy or corpectomy on a subject in which a positioning tool thatfunctions as both a distraction instrument and an implant positioningtool is inserted between adjacent vertebrae. The positioning tool caninclude two or more positioning rails. In some embodiments, thepositioning tool is a combination distractor caliper, as describedabove. The positioning tool can be used to enlarge an intervertebralspace and locked. The scale can then be used to determine theappropriately sized spinal implant. The spinal implant can be slidablyengaged into the intervertebral space. The intervertebral implantincludes one or more positioning grooves configured to receive acorresponding positioning rail from the positioning rails on thepositioning tool. The positioning tool can then be slidably removed fromthe intervertebral space along the positioning grooves withoutdisturbing the implant.

The method can include packing graft material into the central void ofthe implant while the implant is in situ. In some embodiments, theimplant can include a multifunctional window leading to a central voidin the implant. An impaction tool having a complementary shape and sizeto mate with the multifunctional window can be used to pack the centralvoid.

The method can further include stabilizing the implant. Stabilizingplacing a stabilization plate on the bone to retain the implant'sposition. The stabilization plate is configured to mate with the implantsuch that when it is placed, the stabilization plate is orientedcorrectly and stays in position while it is adhered to the bone (e.g. byscrews). An affixing tool having puncturing means (e.g. one or moreawls) that correspond to apertures in the stabilization plate can beused to puncture accurately placed holes for the screws. The plate canthen be adhered to the bone, such as by screwing the plate in.

In some embodiments one or more of the positioning grooves is located ona superior implant surface and one or more of the positioning grooves islocated on an inferior implant surface. The positioning tool can haverails corresponding to the positioning rail.

The spinal implant can be selected from any of the implants describedabove, including but not limited to an anterior cervical discectomy andfusion implant, an anterior cervical corpectomy implant, a thoracolumbarimplant, a posterior lumbar interbody fusion implant, a transforaminallumbar interbody fusion implant, or an anterior lumbar interbody fusionimplant.

In some embodiments, one or both of the superior implant surface and theinferior implant surface comprise a feature and/or a textured surfacethat increases the frictional resistance between that surface of theimplant and the adjacent vertebrae compared to the same surface in theotherwise same implant except without the features or texture.

In some embodiments, one or both of the superior implant surface and theinferior implant surface comprise a convex surface.

In some embodiments, each of the superior and inferior positioninggrooves can have a length of about 8 mm to about 60 mm, a diameterperpendicular to the length, wherein the diameter is about 1.5 mm to 2.0mm, and wherein a length of each of the corresponding positioning railsis less than or equal to the length of the superior and inferiorpositioning grooves.

It should be emphasized that the above-described embodiments of thepresent disclosure are merely possible examples of implementations, andare set forth only for a clear understanding of the principles of thedisclosure. Many variations and modifications may be made to theabove-described embodiments of the disclosure without departingsubstantially from the spirit and principles of the disclosure. All suchmodifications and variations are intended to be included herein withinthe scope of this disclosure.

We claim:
 1. A spinal implant, the implant comprising: a superiorimplant surface, wherein the superior implant surface comprises one ormore superior positioning grooves configured to receive a correspondingsuperior positioning rail; an inferior implant surface, wherein theinferior implant surface comprises one or more inferior positioninggrooves configured to receive a corresponding inferior positioning rail;and one or more implant sidewalls separating the superior implantsurface and the inferior implant surface.
 2. The spinal implant of claim1, wherein the superior implant surface engages a superior vertebralsurface when the implant is implanted in the intervertebral space, andthe inferior implant surface engages an inferior vertebral surface whenthe implant is implanted in the intervertebral space.
 3. The spinalimplant according to claim 2, wherein the one or more superiorpositioning grooves and the one or more inferior positioning grooveshave a length extending from an anterior region of the intervertebralspace to a posterior region of the intervertebral space when the implantis implanted in an intervertebral space.
 4. The spinal implant accordingto claim 3, wherein the superior and inferior positioning grooves have alength of about 8 mm to about 60 mm.
 5. The spinal implant according toclaim 4, wherein the one or more superior positioning grooves and theone or more inferior positioning grooves have a diameter perpendicularto the length, wherein the diameter is about 1.5 mm to 2.0 mm.
 6. Thespinal implant according to claim 1, wherein the superior implantsurface comprises two superior positioning grooves.
 7. The spinalimplant according to claim 1, wherein the inferior implant surfacecomprises two inferior positioning grooves.
 8. The spinal implantaccording claim 1, wherein one or both of the superior implant surfaceand the inferior implant surface comprise a feature and/or a texturedsurface that increases the frictional resistance between that surface ofthe implant and the adjacent vertebrae compared to the same surface inthe otherwise same implant except without the features or texture. 9.The spinal implant according claim 1, wherein one or both of thesuperior implant surface and the inferior implant surface comprise aconvex surface.
 10. The spinal implant according to claim 9, wherein theconvex surface has a convexity from about 0.01 mm to 1.0 mm.
 11. Thespinal implant according claim 1, further comprising one or moreradiopaque markers.
 12. The spinal implant according claim 1, furthercomprising a central void space, wherein the central void spacecomprises up to about 90% of the implant volume.
 13. The spinal implantaccording to claim 1, wherein the spinal implant is an anterior cervicaldiscectomy and fusion (ACDF) implant; wherein the spinal implant has aheight at an anterior wall of about 4 mm to 14 mm; wherein the spinalimplant has a height at a posterior wall of about 4 mm to 98 mm; whereinthe spinal implant has a width from a first side wall to a second sidewall of about 12 mm; and wherein the spinal implant has a length fromthe anterior wall to the posterior wall of about 11 mm to 14 mm.
 14. Thespinal implant according to claim 1, wherein the spinal implant is ananterior cervical corpectomy implant; wherein the spinal implant has aheight at an anterior wall of about 14 mm to 100 mm and a width at theanterior wall of about 10 mm to 16 mm; wherein the spinal implant has aheight at a posterior wall of about 4 mm to 100 mm and a width at theposterior wall of about 5 mm to 20 mm; and wherein the spinal implanthas a length from the anterior wall to the posterior wall of about 4 mmto 100 mm.
 15. The spinal implant according to claim 1, wherein thespinal implant is a thoracolumbar implant having a first superiorpositioning groove, a second superior positioning groove, a firstinferior positioning groove, and a second inferior positioning groove;wherein the spinal implant has a height at an anterior wall of about 4mm to 25 mm; wherein the spinal implant has a height at a posterior wallof about 4 mm to 25 mm; and wherein the spinal implant has a width froma first side wall to a second side wall of about 20 mm to 100 mm. 16.The spinal implant according to claim 15, wherein the superior implantsurface and the inferior implant surface are convex.
 17. The spinalimplant according to claim 1, wherein the spinal implant is a posteriorlumbar interbody fusion implant having a superior positioning groove andan inferior positioning groove; wherein the spinal implant has a heightat an anterior wall of about 4 mm to 20 mm; wherein the spinal implanthas a height at a posterior wall of about 4 mm to 20 mm; and wherein thespinal implant has a width from a first side wall to a second side wallof about 4 mm to 14 mm.
 18. The spinal implant according to claim 17,wherein the superior implant surface and the inferior implant surfaceare convex.
 19. The spinal implant according to claim 1, wherein thespinal implant is a transforaminal lumbar interbody fusion implanthaving a superior positioning groove and an inferior positioning groove;wherein the spinal implant has a height at an anterior wall of about 4mm to 20 mm; wherein the spinal implant has a width from a first sidewall to a second side wall of about 4 mm to 20 mm; and wherein theimplant is mediolaterally curved.
 20. The spinal implant according toclaim 1, wherein the intervertebral implant is an anterior lumbarinterbody fusion implant comprising: a first superior positioninggroove, a second superior positioning groove, a first inferiorpositioning groove, and a second inferior positioning groove; furthercomprising a first superior oblique groove, a second superior obliquegroove, a first inferior oblique groove, and a second inferior obliquegroove; wherein the oblique grooves have a larger diameter than thepositioning grooves; wherein the spinal implant has a height at ananterior wall of about 4 mm to 20 mm; wherein the spinal implant has aheight at a posterior wall of about 4 mm to 20 mm; and wherein thespinal implant has a width from a first side wall to a second side wallof about 20 mm to 50 mm.
 21. A system for surgical implants, comprising:a positioning tool comprising at least one positioning rail; and aspinal implant, the spinal implant comprising: a superior implantsurface comprising one or more superior positioning grooves configuredto receive the at least one corresponding superior positioning rail; aninferior implant surface comprising one or more inferior positioninggrooves configured to receive the at least one corresponding inferiorpositioning rail; and one or more implant sidewalls separating thesuperior implant surface and the inferior implant surface.
 22. Thesystem of claim 21, further comprising a stabilization plate comprisingscrew placement apertures.
 23. The system of claim 22, wherein thestabilization plate comprises a protrusion that has a complementaryshape to mate with a multifunctional widow of the spinal implant. 24.The system of claim 21, further comprising an affixing tool comprisingat least one awl, and wherein the at least one awl is located on theaffixing tool in a position configured to mate with screw placementapertures on a stabilization plate.
 25. The system of claim 24, whereinthe stabilization plate comprises a protrusion, and the affixing toolcomprises a receiver having a complementary shape to the protrusion. 26.The system of claim 25, further comprising an impaction tool having acomplementary shape and size to mate with a multifunctional window ofthe spinal implant.
 27. The system of claim 25, wherein the impactiontool comprises safety rails that prevent over-impaction.
 28. The systemof claim 27, wherein the positioning tool comprises at least oneremoveable attachment, wherein the positioning rail is on theattachment.
 29. The system of claim 21, further comprising: astabilization plate comprising screw placement apertures, thestabilization plate comprising a protrusion having a complementary shapeto mate with a multifunctional widow of the spinal implant; and anaffixing tool comprising at least one awl, wherein the at least one awlis located on the affixing tool in a position configured to mate withthe screw placement apertures on the stabilization plate and wherein theaffixing tool comprises a receiver having a complementary shape to theprotrusion.
 30. The system of claim 29, further comprising an impactiontool having a complementary shape and size to mate with amultifunctional window of the spinal implant.